Class 2 Device Recall OmniTom / Model NL5000

• Date Initiated by Firm: July 15, 2020
• Create Date: August 07, 2020
• Recall Status: Terminated on July 13, 2021
• Recall Number: Z-2772-2020
• Recall Event ID: 86052
• 510(K)Number: K171183
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
• Code Information: UDI: 08806167789220; all NL5000 systems with software version before 05.01.01; Serial Numbers: 00008 00009 00010 00011 00012 00013 00016 00018 00020 00021 00022 00023 00024 00027 00030 00031 00032 00033 00035 00036 00037 00040 00043 00044 00045 00046 00007 00014 00017 00028 00034 00038 00039 00041 00042
• Recalling Firm/ Manufacturer: NeuroLogica Corporation; 14 Electronics Ave; Danvers MA 01923-1011
• For Additional Information Contact: Dr. Ninad Gujar; 978-564-8632
• Manufacturer Reason for Recall: There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in patient treatment if proper use instructions are not followed.
• FDA Determined Cause: Device Design
• Action: Urgent  Medical Device Correction notification letters were sent to customers beginning 7/15/20. Users may continue to use the NL5000 system if proper instructions for use are followed as described in user manual (1-NL5000-060). This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. The system label is located near the main input plug or on the side of the system. NeuroLogica will undertake the voluntary corrective action considering the possibility of delay in patient treatment if the scanner is not operational. The hardware and software upgrades provide additional safeguards by improving the design to minimize any risks of the above situations from happening. Service engineers will correct all affected devices free of charge and contact you to arrange for the correction. All corrections in the field will be completed by December 31, 2020. If you need any further information or have any concerns with this issue, then please contact your local representative. Customer Reply Form This reply form is to confirm receipt of the enclosed NeuroLogica Medical Device Field Safety Notice [FSN-NL5000_071620] regarding the potential issues related to the operational state of the scanner and the required software and hardware upgrades. Please read the Notice and indicate the appropriate answers to the questions below.
• Quantity in Commerce: 35
• Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, India, Portugal, Singapore, Slovak Republic, Thailand, Turkey, UK.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAK and Original Applicant = NeuroLogica Corporation,